Neoplasms, MalignantPhase 1QT-CabNCT01087021
Effect of Cabazitaxel on the QTc Interval in Cancer Patients
A Phase 1 study testing Cabazitaxel (XRP6258) in people with Neoplasms, Malignant, run by Sanofi at 15 sites in 5 countries.
Trial summary
Primary Objective: To assess the potential effect on QTcF interval (QTc Fridericia) of cabazitaxel in cancer patients Secondary Objectives: To assess the effects of cabazitaxel on heart rate (HR), QT, QTcB (Bazett's correction), and QTcN (population specific correction) intervals To assess the clinical safety of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Malignant
- What is being tested?
- Cabazitaxel (XRP6258)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 15 sitesin 5 countries
- Study dates
- Mar 2010to Nov 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed solid malignancy that is metastatic or unresectable, and for which standard curative measures do not exist, and a treatment with a novel taxane agent is considered.
Who cannot join
- Conditions with screening ECG repolarization difficult to interpret, or showing significant abnormalities. This includes, but is not limited to: high degree AV block, pace-maker, atrial fibrillation or flutter
- QTcF >480 msec on screening Electrocardiogram (ECG)
- Significant hypokalemia at screening (serum potassium <3.5 mMol/L)
- Significant hypomagnesemia at screening (serum magnesium <0.7 mMol/L) (Note: Patient may be enrolled after correction of these laboratory abnormalities)
- Patient receives (and cannot discontinue), or is scheduled to receive a QT-prolonging drug
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
15 sites in 5 countries.
15 sites in 5 countries
United States8 sites
Sanofi-Aventis Investigational Site Number 840009
Bethlehem, Pennsylvania, 18015
Sanofi-Aventis Investigational Site Number 840005
Decatur, Illinois, 62526
Sanofi-Aventis Investigational Site Number 840007
Kansas City, Missouri, 64128
Sanofi-Aventis Investigational Site Number 840010
Paducah, Kentucky, 42002
Sanofi-Aventis Investigational Site Number 840003
Salt Lake City, Utah, 84132
Sanofi-Aventis Investigational Site Number 840006
San Diego, California, 92103
Sanofi-Aventis Investigational Site Number 840002
San Francisco, California, 94115
Sanofi-Aventis Investigational Site Number 840008
Wichita, Kansas, 67214
Belgium2 sites
Sanofi-Aventis Investigational Site Number 056002
Brussels, 1200
Sanofi-Aventis Investigational Site Number 056001
Ghent, 9000
Denmark2 sites
Sanofi-Aventis Investigational Site Number 208002
Herlev, 2730
Sanofi-Aventis Investigational Site Number 208001
København Ø, 2100
Sweden2 sites
Sanofi-Aventis Investigational Site Number 752002
Lund, 221 85
Sanofi-Aventis Investigational Site Number 752001
Uppsala, 751 85
Netherlands1 site
Sanofi-Aventis Investigational Site Number 528001
Maastricht, 6229 HX
About this study
Official title: QT-Cab: An Open-Label Study to Investigate the Effect of Cabazitaxel on the QTc Interval in Cancer Patients
Primary Objective:
- To assess the potential effect on QTcF interval (QTc Fridericia) of cabazitaxel in cancer patients
Secondary Objectives:
- To assess the effects of cabazitaxel on heart rate (HR), QT, QTcB (Bazett's correction), and QTcN (population specific correction) intervals
- To assess the clinical safety of cabazitaxel
- To assess cabazitaxel plasma concentrations at Cycle 1 at early timepoints (during infusion and up to 5h post end of infusion)
Read the detailed description
The main period of the study consists of a maximum of 21-day screening phase, then first 2 treatment cycles with cabazitaxel. End of main period will be Cycle 3 or 30 days after last dose if patient discontinues study after 1 or 2 treatment cycles. The duration for a patient for the main period of the study will be about 9 to 10 weeks (screening, 2 cycles).
After Cycle 2, patients will have the option to continue to receive cabazitaxel and should be followed for safety reporting until 30 days after the last dose of cabazitaxel.
- Conditions
- Neoplasms, Malignant
- Being tested
- Cabazitaxel (XRP6258)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cabazitaxel (XRP6258)Drug
Pharmaceutical form:solution for infusion
Route of administration: intravenous
| Study group | Role | What they receive |
|---|---|---|
| cabazitaxel | Experimental | At every cycle (every 3 weeks), on Day 1, patients will receive cabazitaxel, administered by intravenous (IV) infusion over 1 hour, at 25 mg/m2.
An IV premedication regimen composed of up to 4 treatments (antihistamine, corticosteroids, H2 antagonist other than cimetidine at all cycles, plus palonosetron at cycle 1) will be administered before cabazitaxel infusion. Receives: Drug: Cabazitaxel (XRP6258) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in QT interval corrected calculation by Fridericia method
Measured: Cycle 1, Day 1
Secondary outcomes (4)
Change from baseline in Heart rate, QT, QTcB (QT interval corrected calculation by Bazett method) and QTcN (QT interval with a population-specific correction formulae) intervals
Measured: Cycle 1, Day 1
Other ECG parameters : PR, QRS intervals and ECG morphology
Measured: Cycle 1, Day 1
Clinical safety based on adverse events, serious adverse event, laboratory assessments according to the National Cancer Institute- Common Terminology Criteria for Adverse Events v4.0 grade scaling
Measured: up to treatment discontinuation + 30 days over a maximum study period of 20 months
Cabazitaxel plasma concentrations, Cmax and partial AUC -
Measured: Cycle 1, Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionApr 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasms, MalignantStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01087021
- Sponsor's protocol ID
- TES10884
- Other IDs
- 2009-016864-35, U1111-1116-5677, 2009
- Acronym
- QT-Cab
- Status last verified
- Dec 2011
- First submitted
- 12 Mar 2010
- Last updated
- 16 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QT-Cab: An Open-Label Study to Investigate the Effect of Cabazitaxel on the QTc Interval in Cancer Patients
- ClinicalTrials.gov ID
- NCT01087021
- Acronym / sponsor ID
- QT-Cab / TES10884
- Conditions
- Neoplasms, Malignant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 15 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
- To assess the potential effect on QTcF interval (QTc Fridericia) of cabazitaxel in cancer patients
Secondary Objectives:
- To assess the effects of cabazitaxel on heart rate (HR), QT, QTcB (Bazett's correction), and QTcN (population specific correction) intervals
- To assess the clinical safety of cabazitaxel
- To assess cabazitaxel plasma concentrations at Cycle 1 at early timepoints (during infusion and up to 5h post end of infusion)
Detailed description
The main period of the study consists of a maximum of 21-day screening phase, then first 2 treatment cycles with cabazitaxel. End of main period will be Cycle 3 or 30 days after last dose if patient discontinues study after 1 or 2 treatment cycles. The duration for a patient for the main period of the study will be about 9 to 10 weeks (screening, 2 cycles).
After Cycle 2, patients will have the option to continue to receive cabazitaxel and should be followed for safety reporting until 30 days after the last dose of cabazitaxel.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cabazitaxel | Experimental | Drug: Cabazitaxel (XRP6258)At every cycle (every 3 weeks), on Day 1, patients will receive cabazitaxel, administered by intravenous (IV) infusion over 1 hour, at 25 mg/m2. An IV premedication regimen composed of up to 4 treatments (antihistamine, corticosteroids, H2 antagonist other than cimetidine at all cycles, plus palonosetron at cycle 1) will be administered before cabazitaxel infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Histologically or cytologically confirmed solid malignancy that is metastatic or unresectable, and for which standard curative measures do not exist, and a treatment with a novel taxane agent is considered.
Key exclusion criteria (6 listed)
- Conditions with screening ECG repolarization difficult to interpret, or showing significant abnormalities. This includes, but is not limited to: high degree AV block, pace-maker, atrial fibrillation or flutter
- QTcF >480 msec on screening Electrocardiogram (ECG)
- Significant hypokalemia at screening (serum potassium <3.5 mMol/L)
- Significant hypomagnesemia at screening (serum magnesium <0.7 mMol/L) (Note: Patient may be enrolled after correction of these laboratory abnormalities)
- Patient receives (and cannot discontinue), or is scheduled to receive a QT-prolonging drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cabazitaxel (XRP6258)Pharmaceutical form:solution for infusion Route of administration: intravenous | Drug | cabazitaxel |
Primary outcome
Change from baseline in QT interval corrected calculation by Fridericia method
Time frame: Cycle 1, Day 1
4 secondary outcomes
Change from baseline in Heart rate, QT, QTcB (QT interval corrected calculation by Bazett method) and QTcN (QT interval with a population-specific correction formulae) intervals
Time frame: Cycle 1, Day 1
Other ECG parameters : PR, QRS intervals and ECG morphology
Time frame: Cycle 1, Day 1
Clinical safety based on adverse events, serious adverse event, laboratory assessments according to the National Cancer Institute- Common Terminology Criteria for Adverse Events v4.0 grade scaling
Time frame: up to treatment discontinuation + 30 days over a maximum study period of 20 months
Cabazitaxel plasma concentrations, Cmax and partial AUC -
Time frame: Cycle 1, Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
15 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cabazitaxel (XRP6258) in people with Neoplasms, Malignant, run by Sanofi at 15 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Belgium, Denmark, Sweden, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in QT interval corrected calculation by Fridericia method (time frame: Cycle 1, Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2011.